Atellica® Solution Lot and Pack Calibration Troubleshooting Video

Italicus solution lot and pack calibration troubleshooting. At the completion of this job aid, you will be able to describe how the Italicus solution utilizes both lot and pack calibration intervals. And describe how to troubleshoot common issues related to lot and pack calibrations. You will be able to print a PDF copy of this job aid to refer to by selecting the resources link at the top right corner. Reagent calibration should be performed for a variety of reasons, including when a new reagent lot is loaded onto the system and when the calibration interval expires. The Italicus solution manages reagent calibration by using both lot calibrations and pack calibrations. The instructions for use contains the frequency requirements for lot and pack calibrations for each assay. The following slides will discuss the difference between lot and pack calibrations. Let's discuss the differences between lot calibration intervals and pack calibration intervals. First, it is important to recognize that a reagent pack aging on the shelf is not the same as one aging on the system. The stability of a reagent that is on the shelf is longer than one that is on board the system. Said slightly differently, a reagent shelf life is longer than its obes. Also, the shelf life of reagents applied to the entire lot, whereas obsi is based on individual packs. This phenomenon of shelf life and on board stability gives rise to the idea of lot or pack well calibration. Generally lot calibration intervals are longer than packed calibration intervals. Also, lot calibration applies to the entire lot, whereas the pack well calibrations apply to a single pack or well. The lot calibration interval starts when a reagent pack with a new lot is calibrated within 24 hours after it is loaded on the system. For the IM analyzer or 24 hours after the well is pierced by the Ch analyzer. The lot calibration will be valid for any pack within the same lot that is loaded on the system until the lot calibration interval expires. A reagent pack that uses a lot calibration to calculate results for the duration of the pack calibration interval orlon expiration, whichever comes first. The pack calibration interval actually applies to both reagent packs and wells within reagent packs. On the system there are two wells. In each reagent pack which are treated as separate reagents by the system. So on the analyzer, a pack calibration is actually a well calibration. The pack or well calibration interval is valid for an individual pack for the IM analyzer or well for the analyzer and not used for subsequent packs placed on the system. This is useful for labs that perform a low volume of tests because they can avoid disposing of reagent packs due to QC shifts seen when calibrating aged packs. In this slide we will look closer at the impact of using lot and pack calibrations. In the case of high volume assays, the system that is performing a large amount of tests for an assay uses the entire contents of the first pack for the IM analyzer or well for the analyzer of a lot before the pack calibration interval expires. When the first pack or well is replaced with a second pack or well of the same lot, the system uses the original lot calibration established by the 1st reagent pack or well to calculate test results. Subsequent packs or wells of the same lot do not require calibration when loaded or pierced until the lot calibration interval expires. High volume assays use lot calibrations, which leads to fewer calibrations for the life of a lot of reagents. In the case of low volume assays, the system that is performing a smaller amount of tests for an assay does not use the entire contents for the first pack or well of a lot before the pack calibration interval expires. Recalibration is required to ensure continued use of the pack or well on the system. The system uses the pack calibration to calculate patient results. Low volume assays use pack or well calibrations which lead to more stable QC results as reagents age on the system. Now let's look at a simple example. In this example, the lot calibration interval is 180 days and the pack calibration interval is 9 days. If you load a new pack with a new lot and calibrate within 24 hours after it is loaded, this will be the lot calibration. In the case of high volume assays, the lab is running through reagent quickly. If they are loading new packs with the same lot at least every nine days, they do not need to calibrate the new pack or well, because the lot calibration does not expire until day 180. The lab would only need to re calibrate every 180 days. In the case of low volume assays, nine days after the start of using the lot calibration, if the Packer well is still being used and needs to be re calibrated because the Packer well calibration interval has now expired, the calibration is a pack or well calibration. If the pack remains on board, it will have to be re calibrated every nine days until it reaches the onboard stability. In summary, you don't need to calibrate until you load a new lot. A pack is in use for more than nine days, or the lot calibration interval expires at 180 days. Now let's look at some real life examples. Following the first example, in this case study, we have an assay that has a lot calibration interval of 180 days and a pack calibration interval of nine days. The lab loaded a new reagent pack with a new lot and performed a lot calibration. Question one. What a calibration need to be performed if the reagent in well one was used within 8 days? No, because the nine day pack calibration interval has not yet been reached. Question 2. What a calibration need to be performed if the reagent and well one was not completely used up after 9 days. Yes, a pack calibration would be performed because the pack calibration interval has now expired. Question 3. Which calibration would be used if a calibration was performed after the 9th day? Upack calibration. Question 4. The reagent on board stability and well one is now expired. Which calibration would be used when, well, two is pierced? When well to his pierced, it would inherit the existing lot calibration which was performed on day one. Now for our next case study cholesterol another chemistry assay with two wells in each pack. The lab supervisor notices some imprecision in the QC data for an assay. To troubleshoot the imprecision they look at when calibrations have been performed. On day one, a lot calibration was created. Following this, the QC data was within range, but not right on the mean. Question one. At day 7A, pack calibration is performed on the same pack. Following this, how does the QC data look? The QC data is now on the mean. Question 2. At day 12A, new pack is loaded. What type of calibration would be used for the new pack? The existing lot calibration that was created on day one. Question 3. How does the QC data look following day 12? The QC data is within range but not right on the mean. Seven days later, on Day 19, the pack calibration interval expires. For the second pack. So a pack calibration is performed and the QC is back to the mean. Question 4. What could be causing the imprecision in the QC mean? Imprecision can be caused by different calibrations being active. In this example, the CALIBRATER'S used for the initial lot calibration were not fresh. When troubleshooting that in precision, it is important to be aware if you are looking at a pack calibration or lot calibration. Our last example involves the replacement of the source lamp on the Ch analyzer. Question one. What must be done after replacing the source lamp? Refer to online help. Wait one hour after replacing the lab perform Ch auto check after auto check completes, perform QC. Question 2. What must be done if QC is out of range post lab change? Perform a calibration to address QC. Question 3. What is the most likely calibration that will be performed? Pack calibration or lot calibration? Pack calibration chances are the reagent has been on the system for longer than 24 hours. Question 4. What happens when a new well is pierced after the pack calibration was performed? The system will revert to the lot calibration that was performed before the replacement of the lamp. Question 5. How can this pack calibration issue be solved? Load fresh reagent and perform a lot calibration or inactivate a well and perform a lot calibration on well too. This example applies to any parts that are changed for assay troubleshooting, IE probes, mixer, reaction or dilution, Q vets, etc.

AteLLica@ Solution Lot and Pack Calibration SIEMENS ... Healthineers SIEMENS ... Oueruieuj of Pack and Lot Calibration InteruaLs Lot and Pack Calibration Key Benefits OueruieujJ of Pack and Lot Calibration InteruaLs Oueruieu-J of Pack and Lot Calibration InteruaLs Troubleshooting Case Study #1 Troubleshooting Case Study #3 High Volume Assay us Lou Volume Assay Example High Volume Assay us Low Volume Assay Example Calibration Frequency Healthineers Calibration After Replacing a Part Imprecision Caused by Bad Lot Calibration Please note that the learning material is for training purposes only. The system utilizes both reagent lot and reagent pack calibration intervals to determine when a reagent needs to be calibrated. High Volume Assays: Lowh Volume Assays: Reagent calibration should be performed according to Lot Calibration Interval = 180 days pack calibration interval expires. Pack/Well Calibration Interval = 9 days Pack/WeII Calibration Interval 7 days Lot Calibration Interval Lotk Calibration Interval = 180 days Pack Calibration Interval pack calibration interval expires. Pack/WeII Calibration Interval 7 9 days Pack/Well Calibration Interval = 9 days Lot Calibration Interval = 180 days Pack Calibration Interval expires. Lot Calibration Interval Lotk/Well Calibration Interval = 980 days Pack/Well Calibration Interval = 980 days Lot Calibration Interval = 10 days Lotk Calibration Interval = 10 days Lotk Calibration Interval = 50 days Lot Calibration Interval = 50 days Pack/WeII Calibration Interval = 50 days Lack/WeII Calibration Interval = 9 days On day 1, a lot calibration was created. Following this, the QC data was Atellica Solution uses automation, What must be done after replacing the source lamp on the Atellica@ CH Analyzer? (Refer to Online Help) the following: • This is the case for a system that is performing a large amount of tests for an assay, Pack Calibration Interval pack calibration interval expires. Pack/Well Calibration Interval = 9 days Pack/Well Calibration Interval = days Pack/WeII Calibration Interval = 9 days Pack/WeII Calibration Interval 7 days Pack/WeII Calibration Interval 7 9 days Lot Calibration Interval = 180 days Pack/WeII Calibration Interval 7 days Lotk Calibration Interval Pack Calibration Interval = 180 days calibration interval expires Lot Calibration Interval = 10 days Lot Calibration Interval Pack Calibration Interval = days Pack Calibration Interval = 90 days Lot Calibration Interval = 1 days Pack Calibration Interval = 50 days on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. on a regular basis and does not necessarily refect the latest version of the software and hardware available at the time of the training. within range but not right on the mean. as well as lot and pack and uses the entire contents of the first pack for 1M, or well for CH, of a lot before the Wait 1 hour after replacing the lamp, perform CH Autocheck. After Autocheck completes, perform QC. Lotk Calibration Interval = 50 days Onboard Stability Interval = 26 days pack calibration interval expires. Pack Calibration Interval Pack/WeII Calibration Interval 7 days Lot Calibration Interval = 50 days pack calibration interval expireys. Pack/WeII Calibration Interval 7 9 days Lotk Calibration Interval = 10 days • Expired assay reagent calibration Pack Calibration Interval Lotk Calibration Interval = 180 days Lotk Calibration Interval Pack/WeII Calibration Interval = 980 days Lot Calibration Interval = 90 days Pack/Well Calibration Interval = 180 days calibration interval expires A new reagent pack was loaded with a new lot and performs a calibration on day 1. • Starts when a reagent pack with a new lot is calibrated within 24 hours after it is loaded on the system for 1M reagents, or 24 hours after the calibration. calibrations to: Lack Calibration Interval = 180 days pack calibration interval expires. Pack Calibration Interval = 9 days Lotk Calibration Interval = 50 days Pack Calibration Interval = 9i days Pack Calibration Interval = 980 days Pack Calibration Interval = days Pack Calibration Interval = 90 days Pack/WeII Calibration Interval 7 days Lotk Calibration Interval pack calibration interval expireys. Pack/Well Calibration Interval = 9 days Lotk Calibration Interval = 10 days Lat Calibration Interval = 50 days Pack/Well Calibration Interval = days Lot Calibration Interval = 10 days The Operators Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. pack, so a packlwell calibration is performed, and the QC is back to the On day 7, a pack/well calibration is performed on the same pack. well is pierced for CH reagents • New assay reagent lot The lab supervisor notices some imprecision in the QC data • When the first pack/well is replaced with a second pack/well of the same lot, the Following this, how does the QC data look? What must be done if QC is out of range, post lamp change? • The lot calibration will be valid for any pack with the same lot that is loaded on the system until the lot calibration interval expires Would a calibration need to be performed if the reagent in well I was used within 8 days? Note: Some functions shown in this material are optional and might not be part of your system. • Save labs money If you load a new pack with a new lot and use it to calibrate shortly after it is loaded (within 24 hours), this will be the lot for an assay. To troubleshoot the imprecision, they look at • Replacement of major system components or service system uses the original lot calibration established by the first reagent pack/well to The QC data is now on the mean Perform a calibration to address QC. No • A reagent pack that uses a lot calibration to calculate results for the duration of the Pack calibration interval or Lot expiration, whichever calibration. calibrations to: when calibrations have been performed. calculate test results. • Extend the calibration intervals On day 12, a new pack is loaded. What type of calibration will be used On day 1 2, a new pack is loaded. What type of calibration will be used comes first Would a calibration need to be performed if the reagent in well I was used within 8 days?d Would a calibration need to be performed if the reagent in well 1 was notd completely used High Volume Assays: • Subsequent packs/wells of the same lot do not require calibration when loaded/ on assays for the new pack? What is the most likely calibration that will be performed: pack/well calibration or lot calibration? Lotk Calibration Interval pack calibration interval expires. Pack/Well Calibration Interval = days Pack/Well Calibration Interval = 1 days pack calibration interval expires Pack Calibration Interval 7 days Pack/Well Calibration Interval = 9 days Pack Calibration Interval Pack/WeII Calibration Interval 7 days Lotk Calibration Interval Pack Calibration Interval = 9 days Lot Calibration Interval = 180 days Pack/Well Calibration Interval = 90 days Lotk Calibration Interval = 10 days Lotk Calibration Interval = 180 days 110 up after 9 days? At any point during the 180 days after creation of the lot calibration, if you remove the original pack and load a new pack pierced until the lot calibration interval expires. The existing lot calibration (created on day 1) • Maintain quality control Pack Pack/well calibration — chances are the reagent has been on the system for longer than 24 hours. with the same lot, or pierce the second well of the pack, you do not need to calibrate the new pack/well because the lot Yes • Laboratory quality control programs and procedures • On the CH analyzer, a pack calibration is actually a well calibration. There are 2 wells in most CH packs, which are treated as separate reagents High volume assays use lot calibrations which leads to fewer calibrations for the life cal cal g2 • Increase efficiency for labs with How does the QC data look following day 12? by the system calibration does not expire until day 180. If you keep replacing packs within 9 days, you only need to recalibrate every 180 of a lot of reagents. both a high and low volume of All names and data of patients, parameters and configuration dependent designations are fictional and examples only. The QC data is within range but not right on the mean Which calibration would be used if a calibration was performed after the 9th day? days. • The pack/well calibration interval is valid for an individual pack for 1M or well for CH, and not used for subsequent packs/wells placed on the What happens when a new well is pierced after the pack/well calibration was performed? The Atellica Solution manages reagent calibration by tests system Lot and Pack Calibration Troubleshooting Lot and Pack Calibration Key Benefits Lot and PackCaLibration Troubleshooting On day 1 9, the pack/well calibration interval expires for the second On day 19, the pack/well calibration interval expires for the second The system will revert to the lot calibration that was performed before the replacement of the lamp. High Volume Assays: Lowh Volume Assays: • This is the case for a system that is performing a lmarger amount of tests for an assay, • This is the case for a system that is performing a smaller amount of tests for an assay, This is the case for a system that is performing a smaller amount of tests for an assay • Useful for labs that perform a low-volume of tests because they can avoid disposing of reagent packs due to QC shifts seen when calibrating On day 7, a pack/well calibration is performed on the same pack. pack, so a packlwell calibration is performed, and the QC is back to the 9 days after the start of using the lot calibration, if the pack/well is still being used, it needs to be re-calibrated because the and does not use the entire contents for the first pack/well of a lot before the pack aged packs mean. pack/well calibration interval has now expired. The calibration is a pack/well calibration, because a lot calibration must be 95 85 90 How can this pack/well calibration issue be solved? when well 2 is pierced? pack calibration interval expires. Lotk Calibration Interval = 10 days Pack Calibration Interval Pack Calibration Interval 7 9 days Lot Calibration Interval = 180 days Pack/WeII Calibration Interval = 9 days Lack Calibration Interval = 10 days The Instructions For Use (IFU) contains the frequency Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability. done within the 180 day lot calibration limit for a newly loaded pack/pierced well. If the pack remains onboard, it will have What could be causing the imprecision? The system tracks lot and pack calibration and displays reminders when calibration or re-calibration of an assay reagent pack is due. When well 2 is pierced, it would inherit the existing lot calibration which was • Recalibration is required to ensure continued use of the pack/well on the system. The Fresh to be recalibrated every 9 days until it reaches the reagent's onboard stability. Imprecision can be caused by different calibrations being active. In 110 95 90 85 system uses the pack/well calibration to calculate patient results. NOTE: In order for a calibration to qualify as a lot calibration, the calibration must be done within Exit • Low volume assays use pack/well calibrations which lead to more stable QC results as 24 hours after a new 1M pack is loaded on the system or 24 hours after a CH well is pierced. If a 85 new pack/well is not calibrated within 24 hours, the calibration will be a pack calibration. be aware if you are looking at a pack calibration or lot calibration. 12 1618 20 26 14 14 12 18 16 110 24 12 18 110 20 20 26 22 22 24 20